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DIN EN IEC 62304
Health software - Software life cycle processes
DIN EN IEC 81001-5-1
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
DIN EN IEC 81001-5-1 Beiblatt 1
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle; Supplement 1: Interpretation sheet 1 (IEC 81001-5-1:2021/ISH1:2025)
ISO/CD 81001-1
Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts
IEC/AWI 81001-5-1
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
prEN IEC 81001-5-1
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
prEN ISO 24973
Digital Therapeutics - Product Requirements
DIN EN ISO 24973
Digital Therapeutics - Product Requirements